Revision implant augments, systems, and methods

ABSTRACT

A revision implant component comprising a body having a plurality of screw holes and a tapered head configured to engage a talar dome component of a multi-component ankle prosthesis. A surgical method is disclosed which includes creating an incision in a patient, exposing a multi-component ankle prosthesis implanted in a patient, disassembling at least one component of the multi-component ankle prosthesis, affixing a revision implant component to non-damaged bone using screws, and coupling the revision implant component to a talar dome of the multi-component ankle prosthesis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Divisional Application of U.S. patent applicationSer. No. 14/403,829 filed Nov. 25, 2014, which is a national phase entryunder 35 U.S.C. 371 of international patent application No.PCT/US2014/052301, filed Aug. 22, 2014, the entirety of which isincorporated herein by reference.

FIELD OF DISCLOSURE

The disclosed augments, systems, and methods relate to orthopedicimplants. More particularly, the disclosed augments, systems, andmethods relate to augment inserts for orthopedic implant revisions.

BACKGROUND

Total joint replacements are orthopedic implants for repairing orreplacing a natural joint. Examples of common joints that are replacedby a total joint replacement include, but are not limited to, hips,ankles, and shoulders. The ultimate goal with any total jointsreplacement is to approximate the function and structure of thenatural, healthy structures that the implant or prosthesis is replacing.

In many instances, bone adjacent to an implant suffers from bone loss,for example from osteolysis, over a prolonged period of time following atotal joint replacement. In some cases, plastic or metal wear particlesfrom operation of the prosthesis trigger an autoimmune reaction whichleads to bone resorption. As bone structure is resorbed bone voids areformed which can loosen the fixation of the prosthesis within thepatient, causing greater problems for the patient.

SUMMARY

In some embodiments, a revision implant component comprises a bodyincluding an inner side and an outer side, tapered such that the widthof a front side is greater than the width of a back side, the bodydefining a plurality of screw holes and having a tapered head configuredto engage a talar dome component of a multi-component ankle prosthesis.

In some embodiments, a surgical method includes creating an incision ina patient, exposing a multi-component ankle prosthesis implanted in apatient, disassembling at least one component of the multi-componentankle prosthesis, affixing a revision implant component to non-damagedbone using screws, and coupling the revision implant component to atalar dome of the multi-component ankle prosthesis. The revision implantcomponent has a body including a head configured to engage a feature ofa component of the multi-component ankle prosthesis for coupling therevision implant component to the component of the multi-component ankleprosthesis.

In some embodiments, a surgical method includes creating an incision ina patient, exposing a multi-component ankle prosthesis implanted in apatient, disassembling at least one component of the multi-componentankle prosthesis, resecting damaged bone adjacent to the at least onedisassembled component of the multi-component ankle prosthesis,selecting a revision implant component from a kit containing a pluralityof a revision implant components based on the desired thickness of theselected a revision implant component as a function of the depth of boneresected, affixing the revision implant component to non-damaged boneusing screws, and coupling the revision implant component to a talardome of the multi-component ankle prosthesis. The revision implantcomponent has a body including a tapered head configured to operativelyconnect with a talar dome of the multi-component ankle prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a profile view of the top of one example of a revisionimplant component in accordance with some embodiments.

FIG. 1B is a profile view of the top of one example of a revisionimplant component in accordance with some embodiments.

FIG. 2A is a profile view of the top of one example of a revisionimplant component in accordance with some embodiments.

FIG. 2B is a profile view of the top of one example of a revisionimplant component in accordance with some embodiments.

FIG. 3A is an isometric view of one example of a revision implantcomponent in accordance with some embodiments.

FIG. 3B is an isometric view of one example of a revision implantcomponent in accordance with some embodiments.

FIG. 4A is a schematic diagram of the placement of a revision implantcomponent in accordance with some embodiments.

FIG. 4B is a schematic diagram of the placement of a revision implantcomponent in accordance with some embodiments.

FIG. 5 is a flow diagram of a method in accordance with someembodiments.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. The drawing figures are notnecessarily to scale and certain features may be shown exaggerated inscale or in somewhat schematic form in the interest of clarity andconciseness. In the description, relative terms such as “horizontal,”“vertical,” “up,” “down,” “top” and “bottom” as well as derivativesthereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing figure under discussion. These relative terms are forconvenience of description and normally are not intended to require aparticular orientation. Terms including “inwardly” versus “outwardly,”“longitudinal” versus “lateral” and the like are to be interpretedrelative to one another or relative to an axis of elongation, or an axisor center of rotation, as appropriate. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise. When only a single machine isillustrated, the term “machine” shall also be taken to include anycollection of machines that individually or jointly execute a set (ormultiple sets) of instructions to perform any one or more of themethodologies discussed herein. The term “operatively connected” is suchan attachment, coupling or connection that allows the pertinentstructures to operate as intended by virtue of that relationship. In theclaims, means-plus-function clauses, if used, are intended to cover thestructures described, suggested, or rendered obvious by the writtendescription or drawings for performing the recited function, includingnot only structural equivalents but also equivalent structures.

The disclosed systems and methods advantageously enable revisions oftotal ankle implants by providing augments designed to be coupled to anoriginal or replacement implant to fill in any gaps formed in the bone.The disclosed systems and methods advantageously provide an effectivecoupling between the augment and an implant component such as a talardome, as well as between the augment and bone unaffected by bone loss.

FIG. 1A illustrates one example of a revision implant component 100A inaccordance with some embodiments. FIG. 1A is a profile view of the topof revision implant component 100A. Revision implant component 100A isconfigured for use with the left ankle joint of a patient.

Revision implant component 100A comprises a body 101 having an innerside 115, outer side 113, front side 103, and back side 111. The body101 defines a plurality of screw apertures 107 and a pair of wireapertures 105. Body 101 further includes a head 109 which protrudes fromupper surface 119.

In some embodiments, the shape of body 101 is configured to match theshape of a talar dome implant. In other embodiments, the shape of body101 is configured to match the shape of the talus, or to match talarbone unaffected by bone loss. Thus, in some embodiments, such as thatillustrated in FIG. 1A, body 101 includes a front side 103 having abulbous shape and a back side 111 having a sulcus shape or groove 121.In some embodiments, back side 111 has a straight, curved, or bulbousedge shape. Similarly, in some embodiments front side 103 has astraight, curved, or grooved shape so as to match the shape of a talardome implant or the talus.

Inner side 115 and outer side 113 are tapered from front to back, suchthat the body 101 is wider near the front side 103 than the back side111. The taper of inner side 115 and outer side 113 is configured tofill the bone voids and rest on the remaining talar bone.

In some embodiments, screw apertures 107 are threaded. In someembodiments, screw apertures 107 include polyaxial locking tabs. In someembodiments, screw apertures 107 are configured to be used with lockingscrews having threaded heads.

In some embodiments, body 101 defines at least one wire aperture 105.Wire apertures 105 assist in the proper placement of revision implantcomponent 100A during surgery. Wire apertures 105 can be configured toreceive k-wires or similar surgical tools to ensure revision implantcomponent 100A is disposed in the proper location as determined by asurgeon and as guided by surgical instrumentation.

Head 109 is configured as an interference connection to a talar dome. Atapered recess in a talar dome receives the tapered head 109, and animpact connection is made between the talar dome and head 109. In someembodiments, the head 109 is a Morse taper. In some embodiments, head109 additionally defines a recess 117.

In still further embodiments, head 109 comprises “timed threads” thatare configured such that when the threaded head 109 and threaded talardome are properly connected, a longitudinal passageway is in alignment.Traditional threaded connections accept varying amounts of torque andrespond with varying alignments; timed threads ensure a properconnection and a specific alignment so long as applied torque is withina predetermined range.

In some embodiments, the thickness of revision implant component 100A,as measured from upper surface 109 to a substantially parallel backsurface (not shown in FIG. 1A, see thickness T in FIG. 4B), isconfigured to fit the thickness of bone lost. In other embodiments, thethickness of revision implant component 100A is configured to fit thethickness required for proper support of a talar dome implant. In otherembodiments, the thickness could be angled or tapered along the lengthof the implant.

FIG. 1B illustrates a second example of a revision implant component100B in accordance with some embodiments. Revision implant component100B is a mirror image of revision implant component 100A, and istherefore configured for use with the right ankle joint of a patient.

FIG. 2A illustrates another example of a revision implant component 200Ain accordance with some embodiments. FIG. 2A is a profile view of thetop of revision implant component 200A. Revision implant component 200Ais configured for use with the left ankle joint of a patient.

Revision implant component 200A is substantially the same as revisionimplant component 100A described above. However, revision implantcomponent 200A includes a curved back side 201 in place of the groove121 in back side 111. Additionally, head 109 defines a notch 203. Insome embodiments, notch 203 has a diameter that is sized and configuredto receive a screw driver or other elongate tool therein. In someembodiments, a screw driver or other elongate tool is used to assist asurgeon in removing the revision implant component 200A.

FIG. 2B illustrates a second example of a revision implant component200B in accordance with some embodiments. Revision implant component200B is a mirror image of revision implant component 200A, and istherefore configured for use with the right ankle joint of a patient.

FIG. 3A illustrates yet another example of a revision implant component300A in accordance with some embodiments. FIG. 3A is an isometric viewof revision implant component 300A. Revision implant component 300A isconfigured for use with the left ankle joint of a patient.

Revision implant component 300A is substantially the same as revisionimplant component 100A described above. However, revision implantcomponent 300A includes an alternate configuration of the plurality ofscrew apertures 307. In this embodiment, screw apertures 307 lack thepolyaxial locking tabs illustrated in FIGS. 1A and 1B. Instead, screwapertures 307 are threaded or include a deformable region adjacent tothe aperture designed to contact the threaded head of a locking screw.

FIG. 3B illustrates a second example of a revision implant component300B in accordance with some embodiments. Revision implant component300B is a mirror image of revision implant component 300A, and istherefore configured for use with the right ankle joint of a patient.

FIGS. 4A and 4B are schematic diagrams of the placement of a revisionimplant component 100A in accordance with some embodiments. Duringsurgery, portions of the talus 405 which were damaged may be resected toform a substantially planar surface 409 of bone which was not damaged(i.e. a surface of healthy or solid bone mass). Revision implantcomponent 100A is affixed to surface 409 using a plurality of screws(not pictured) disposed through screw apertures 107. As illustrated, insome embodiments screw holes 407 are drilled into the talus prior toplacement of the revision implant component 100A. In some embodiments,revision implant component 100A is affixed to talus 405 using lockingscrews with threaded heads. In other embodiments, revision implantcomponent 100A is affixed to talus 405 using non-locking screws, whichmay provide a compressive force to revision implant component 100Aagainst the talus 405.

Once revision implant component 100A is affixed to talus 405, a talardome 401 is operably connected to revision implant component 100A. Asdiscussed above, head 109 of revision implant component 100A is taperedto form an interference connection with a recess 411 defined by talardome 401. In some embodiments, head 109 is a Morse taper. Duringsurgery, the talar dome 401 to revision implant component 100Aconnection is made in situ. The talar dome 401 is placed on revisionimplant component 100A with recess 411 aligned with head 409. Talar dome401 is then impacted to operably connect or bond talar dome 401 withrevision implant component 100A.

FIG. 4B is substantially the same as FIG. 4A and shows a placement of arevision implant component 100A. However, in FIG. 4B, screw holes 407are drilled at a sufficient angle and depth to reach the calcaneus bone403. In some embodiments, the talus 405 is sufficiently damaged that itis desirable to affix revision implant component 100A through the talus405 and to the calcaneus 403. In some embodiments, screw holes 407 aredrilled at a sufficient angle and depth to reach the navicular bone (notshown)

In some embodiments, a plurality of revision implant components, such asthose described above with reference to FIGS. 1A, 1B, 2A, 2B, 3A, and3B, are provided in a surgical kit. Each of the provided revisionimplant components may have a varying shape or thickness (as measuredfrom the upper surface to a substantially parallel back surface—seethickness T in FIG. 4B). By providing varying shapes, thicknesses, andangles, the kit allows a surgeon to conduct an intraoperativedetermination of the best-fitting revision implant component.

A method 500 for implementing a revision implant component is providedin the flow diagram of FIG. 5. The method 500 starts at block 501 andproceeds to block 503, where an incision is made in a patient. At block505, a multi-component implant which was previously installed in thepatient is exposed through the incision.

At block 507, a first component of the multi-component implant isdisassembled and removed from the patient, and at block 509 damaged boneis resected in the area adjacent to the prior location of the removedfirst component. During a revision operation, a multi-componentprosthesis that was previously implant in a patient may be partially orcompletely disassembled. For example, if the multi-component prosthesisis a talar prosthesis, then the talar dome can be decoupled from talarstem by disengaging the Morse taper coupling. When completelydisassembled, the entire multi-component prosthesis is removed from thepatient.

A revision implant component is affixed to non-damaged bone at block511. In some embodiments, the revision implant component is affixed tonon-damaged bone using locking screws or screws with threaded heads. Inother embodiments, the revision implant component is affixed tonon-damaged bone using non-locking screws or screws without threadedheads. In other embodiments, the revision implant component is affixedto non-damaged bone using a combination of locking and non-lockingscrews.

At block 513 a talar dome is placed on the revision implant componentand at block 515 the talar dome is operably connected to the revisionimplant component. In some embodiments, the talar dome is impacted tooperably connect the talar dome to the revision implant component. Insome embodiments, the connection between talar dome and revision implantcomponent is made in situ following affixation of the revision implantcomponent to non-damaged bone. In other embodiments, the head of arevision implant component and the recess of a talar dome are threaded,and are operably connected in situ. Method 500 ends at block 517.

As described above, the revision implant components/augments can have avariety of shapes and geometries. In some embodiments, the revisionimplant components/augments are formed from a plasma sprayed titanium,although other materials including, but not limited to, BIOFOAM®,available from Wright Medical Technology, Inc., and other metal,ceramic, plastic, and bone growth materials.

The size and shape of the revision implant component/augment can beselected after pre-operative assessment using fluoroscopy to identifythe position of a multi-component prosthesis that is implanted in bone,or the selection of the appropriate revision implant component/augmentcan be performed intraoperatively by a surgeon or other healthcareprovider after reviewing the implant site. In some embodiments, therevision implant components/augments are individually sterilized andpackaged while in some embodiments the implant components/augments areprovided in a kit. For example, when provided in a kit, each individualimplant component/augment may be individually packaged and included in alarger container or packaging. However, kits can also be formed withoutpacking multiple implant components/augments in a single package.

As described above, the revision implant components/augments can havedifferent shapes from each other and/or from the shapes of thecomponents of the multi-component prosthesis such that the revisionimplant components/augments can be coupled together to fill a void in abone. Additionally, a single revision implant component/augment caninclude multiple attachment means such as, for example, a taper,threads, a bayonet coupling, to list but only a few possibilities.

Although the devices, kits, systems, and methods have been described interms of exemplary embodiments, they are not limited thereto. Rather,the appended claims should be construed broadly, to include othervariants and embodiments of the devices, kits, systems, and methods,which may be made by those skilled in the art without departing from thescope and range of equivalents of the devices, kits, systems, andmethods.

1-12. (canceled)
 13. A revision implant component, comprising: a taperedbody shaped and dimensioned to substantially align with a top surface ofa resected talus, the body including an inner side and an outer side anddefining a plurality of screw holes with a plurality of polyaxiallocking tabs disposed about the circumference of the plurality of screwholes, and a head configured to engage a talar dome component of amulti-component ankle prosthesis.
 14. The revision implant component ofclaim 13, wherein the body is shaped and dimensioned to substantiallyalign with a bottom surface of a talar dome.
 15. The revision implantcomponent of claim 14, wherein the head is shaped and dimensioned as aMorse taper.
 16. The revision implant component of claim 15, wherein thehead defines a recess and a notch.
 17. The revision implant component ofclaim 16, wherein the body further defines at least one wire hole.
 18. Asurgical method, comprising: creating an incision in a patient; exposinga multi-component ankle prosthesis implanted in a patient; disassemblingat least one component of the multi-component ankle prosthesis; affixinga revision implant component to non-damaged bone using screws; andcoupling the revision implant component to a talar dome of themulti-component ankle prosthesis, wherein the revision implant componenthas a tapered body shaped and dimensioned to substantially align with atop surface of a resected talus, the body including an inner side and anouter side and defining a plurality of screw holes with a plurality ofpolyaxial locking tabs disposed about the circumference of the pluralityof screw holes, and a head configured to engage a talar dome componentof a multi-component ankle prosthesis.
 19. The surgical method of claim18, further comprising resecting damaged bone prior to the step ofaffixing a revision implant component to non-damaged bone using screws.20. The surgical method of claim 19, wherein the revision implantcomponent is affixed to non-damaged bone using screws with threadedheads.
 21. The surgical method of claim 20, wherein the screws areaffixed to the revision implant component and non-damaged bone of thetalus.
 22. The surgical method of claim 21, wherein the screws areaffixed to the revision implant component and non-damaged bone of thecalcaneus or navicular.
 23. The surgical method of claim 22, wherein thestep of coupling the revision implant component to a talar dome furthercomprises attaching an augment between the revision implant componentand the talar dome.
 24. The surgical method of claim 19, wherein thestep of affixing the revision implant component to non-damaged bonefurther comprises attaching an augment between the revision implantcomponent and the non-damaged bone.
 25. The surgical method of claim 19,wherein the revision implant component is coupled to the component ofthe multi-component ankle prosthesis in situ.